Nouvelle déclaration d'incident
No de la demande: 2017-6938
Numéro de référence du titulaire d'homologation: USA-BAYERBAH-2017-US0060065 (Report 446521)
Nom du titulaire (nom légal complet, aucune abbréviation): Bayer inc
Adresse: 2920 Matheson BLVD
Ville: Mississaugua
État: ON
Pays: Canada
Code postal /Zip: L5W5R6
Incident chez un animal domestique
Pays: UNITED STATES
État: UNKNOWN
Inconnu
ARLA No d'homologation ARLA No de la demande d'homologation EPA No d'homologation. Inconnu
Nom du produit: Advantage II Spot-on pipette size unknown
Autre (préciser)
Spot-onOui
Inconnu
Site: Animal / Usage sur un animal domestique
Inconnu
Propriétaire de l'animal
Cat / Chat
Maine Coon
1
Homme
17
Inconnu
Cutanée
>1 wk <=1 mo / > 1 sem < = 1 mois
Unknown / Inconnu
Système
Unknown / Inconnu
Inconnu
Inconnu
Mort
Treatment / Traitement
(p.ex. description des symptômes tels que la fréquence et la gravité
On an unspecified date 2014, a 17 year old, neutered, male, Maine Coon Cat feline, of unknown weight and condition, with no known concomitant medical conditions, was administered 1 tube of Advantage II (cat-unspecified) (Imidacloprid-Pyriproxyfen) topically by the owner. On an unspecified date post application, in 2014, the cat developed twitching. Approximately 1 week post onset, in 2014, the cat recovered without medical intervention. On an unspecified date post recovery, in Sep 2016, the cat died. No necropsy was performed. The reporting party called to discuss the product and not to report the death of this animal. No further information is expected. This case is closed.
Mort
N - Unlikely Reported twitching is not expected with appropriate topical product use. However unknown if applied dosage was according to label. No oral product exposure witnessed. Time to onset is unknown. Other potential causes are more probable. Death is not expected following appropriate topical product application as inconsistent with products pharmacological profile. No signs of allergic/anaphylactic reaction reported. Product has wide margin of safety. Oral LD50 in rat is 642 mg/kg BW. 24-fold overdosage tolerated by cats without showing any side effect. Time to onset for death is exceptionally long (approximately 2 years). Further the reporting party called to discuss the product and not to report the death of this geriatric animal. Overall, even though some information is missing (e.g. time to onset for initial twitching, necropsy details, etc.) and known safety profile of the product, sufficient information exists to rule out product relation completely.